新型口服两性霉素B制剂（iCo-019）单剂量给药于健康人体受试者后的安全性、耐受性及药代动力学：一种替代静脉注射两性霉素B给药的方法
Safety, Tolerability, and Pharmacokinetics of a Novel Oral Amphotericin B Formulation (iCo-019) following Single-Dose Administration to Healthy Human Subjects: an Alternative Approach to Parenteral Amphotericin B Administration.
作者信息
Hnik Peter, Wasan Ellen K, Wasan Kishor M
机构信息
iCo Therapeutics Inc., Vancouver, British Columbia, Canada.
College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.
出版信息
Antimicrob Agents Chemother. 2020 Sep 21;64(10). doi: 10.1128/AAC.01450-20.
Abstract
This study evaluated the safety, tolerability, and pharmacokinetics of a novel oral amphotericin B (AmB) formulation (iCo-019) following single doses to healthy humans. The data from this study suggest that iCo-019 has a long circulation time and systemic exposure without the associated gastrointestinal, liver, and kidney toxicity associated with AmB. This novel oral AmB formulation can serve as a new treatment strategy to overcome the limitations of the use of parenterally administered AmB products.
摘要
本研究评估了新型口服两性霉素B（AmB）制剂（iCo-019）单次给药后对健康人的安全性、耐受性和药代动力学。该研究的数据表明，iCo-019具有较长的循环时间和全身暴露量，且没有与两性霉素B相关的胃肠道、肝脏和肾脏毒性。这种新型口服两性霉素B制剂可作为一种新的治疗策略，以克服胃肠外给药两性霉素B产品使用的局限性。
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